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Completed

NCT Number: NCT04426526

HIFEM for Arms, Lower Limbs, and Oblique Muscles

Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.

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Key information

Conditions

Muscle Tone Increased Muscle Hypertonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Plastic Surgical Associates, Fort Collins, Colorado, United States

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About this study

This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily signed informed consent form
  • BMI ≤ 30 kg/m2
  • Women of child-bearing potential are required to use birth control measures during the whole duration of the study
  • Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
  • Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion criteria

  • Cardiac pacemakers
  • Implanted defibrillators, implanted neurostimulators
  • Electronic implants
  • Pulmonary insufficiency
  • Metal implants
  • Drug pumps
  • Application in the head area
  • Application in the heart area
  • Malignant tumor
  • Injured or otherwise impaired muscles
  • Fever
  • Pregnancy
  • Sensitivity or allergy to latex
  • Breastfeeding
  • Following recent surgical procedures when muscle contraction may disrupt the healing process
  • Application over areas of the skin which lack normal sensation
  • Scars, open lesions and wounds at the treatment area
  • Unrepaired abdominal hernia
  • Patients after Cesarean section delivery

Treatment and study plan

BTL 799-2

Device

High power magnet system

Primary outcomes

  1. Changes in adipose and muscle tissue measured via ultrasound imaging

    Time frame: 7 months

    To determine the effectiveness of the device for strengthening and toning of arms, lower limbs and oblique muscles through changes in surrounding tissues, measured via ultrasound imaging. Using the obtained images, change in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase.

Secondary outcomes

  1. Patient's satisfaction measured via questionnaires

    Time frame: 7 months

    To determine the patient's satisfaction with study treatment for non-invasive strengthening and toning of arms, lower limbs and oblique muscles.The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome where the level of agreement between "strongly agree" and "strongly disagree" should indicate the participant's satisfaction with the therapy.

  2. Incidence Of Treatment-Related Adverse Events

    Time frame: 7 months

    To determine side effects and adverse events (AE) associated with the BTL 799-2 treatment of the arms, lower limbs and oblique muscles. Safety outcomes will include an evaluation of the treatment area to assess and evaluate the following:

    • Muscle pain
    • Temporary muscle spasm
    • Temporary joint or tendon pain
    • Local erythema or skin redness

Sponsors and collaborators

Lead sponsor

BTL Industries Ltd.

Industry

Registry information

Official study title

Efficacy of HIFEM Treatments for Strengthening and Toning of Arms, Lower Limbs and Oblique Muscles

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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